Concentration Effect of Local Anesthetics on Femoral Nerve Block Efficiency

Concentration-Volume Relationship of Bupivacaine in Femoral Nerve Block Efficiency for Postoperative Analgesia in Primary Total Knee Arthroplasty: A Randomized Controlled Double Blind Clinical Trial

US-guided femoral nerve block is used effectively in post-operative pain management in the surgical treatment of the lower extremity. However, the volume and concentration of the local anesthetic drug to be administered remains controversial. In this prospective, randomized, double-blinded study, patients who underwent unilateral primary total knee arthroplasty and successfully performed spinal anesthesia with standard method and dosage, will be selected for US-guided femoral nerve block after the operation. Patients will be divided into three groups with simple randomization. The First group will be determined as the control group (GCont) and only dressing will be applied to the patients. For second group(G125), 0,125% 20 ml local anesthetic and for the third group (G25), 0,25% 10 ml local anesthetic will be administered to the femoral nerve without changing the drug dose (25 mg bupivacaine). Whether there is a difference between post-op analgesia durations, motor block formation, mobilization time and 90° flexion time between the groups will be investigated.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Arthroplasty, Replacement, Knee; Anesthesia and Analgesia; Anesthesia, Conduction
• Intervention / Treatment: Drug: Bupivacaine 0.25% Injectable Solution; Other: Dressing; Procedure: Ultrasound Guided Femoral Nerve Block; Drug: Bupivacaine 0.125% Injectable Solution

Detailed Description

All patients scheduled for total knee arthroplasty will be evaluated before the operation. Eligible patients will be informed about the study and "Numeric Rating Scale" for pain evaluation. Then, patients will be asked for informed consent. After approval from the local research ethics committee, first patient will be recruited for study and patient's group will be determined by dice roll(1,4: GCont - 2,5: G125 - 3,6: G25). Patients who are scheduled for primary total knee arthroplasty under spinal anesthesia with a planned sensory block level between T4 and T7 dermatomes, will be recruited and assigned to a group. After successfully completed surgery, patients will be administered femoral nerve block or only dressing according to the relevant group. Before femoral nerve block is performed, patients will be re-informed about Numeric Rating Scale(NRS) and will be asked to rate their pain at the moment.

• Control Group(GCont) patients will only be applied sterile dressing for the purpose of blinding the patient and the follow-up physician.
• 0.125% Bupivacaine Group(G125) patients will be administered femoral block with 20 ml 0.125% Bupivacaine by an experienced anesthesiologist.
• 0.25% Bupivacaine Group(G25) patients 10ml will be administered femoral block with 0.25% Bupivacaine by an experienced anesthesiologist.

The procedures will be performed in the operating room under both US and nerve stimulator guidance. Patients will be followed-up in post-anesthesia care unit and in the ward for 48 hours. Scheduled and on-demand(Tramadol) medication for analgesia will be ordered and nurses will be informed about the study. Patients' pain scores and ambulation times will be followed-up by another anesthesiologist and on-demand medication will be recorded and monitored from hospital's computer based hospital management program online. Patients will be followed-up for six months after the surgery in order to explore potential long term benefits and complications.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • İzmir
    • Karabaglar, İzmir, Turkey, 35170
      • Izmir Bozyaka Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are scheduled for primary unilateral total knee arthroplasty under spinal anesthesia
• Patients who has informed consent for study

Exclusion Criteria:

• Patient's refusal to participate
• Patients under 18 years of age
• Patients who are undergoing surgery with an anesthesia technique other than spinal anesthesia for any reason (general anesthesia, laryngeal mask application, etc.)
• Patients with known local anesthetic allergy
• Patients with Body mass index > 35
• Patients diagnosed sepsis and bacteriemia,
• Skin infection at the injection site,
• History of coagulopathy or anticoagulant therapy
• Patients with uncontrolled diabetes ,
• Uncoordinated patients,
• Psychological and emotional lability,
• Surgical intervention longer than 3 hours.
• Patients with pre-operative limitation of movement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: GCont; Only dressing will be applied to patients without actually nerve block performed	Other: Dressing; Only dressing will be applied to related area to protect blindness between groups
Active Comparator: G125 Block; Ultrasound Guided Femoral Nerve Block: 20ml Bupivacaine 0.125% Injectable Solution will be administered for femoral nerve block. 5ml %0,5 Bupivacaine will be diluted with 15ml Saline solution.	Procedure: Ultrasound Guided Femoral Nerve Block; Femoral nerve block will be applied post-operatively with guidance of USG and nerve stimulator; Other Names: Regional Anesthesia; Drug: Bupivacaine 0.125% Injectable Solution; Perineural Injection; Other Names: Marcain
Active Comparator: G25 Block; Ultrasound Guided Femoral Nerve Block: 10ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block. 5ml %0,5 Bupivacaine will be diluted with 5ml Saline solution.	Drug: Bupivacaine 0.25% Injectable Solution; Perineural Injection; Other Names: Marcaine; Procedure: Ultrasound Guided Femoral Nerve Block; Femoral nerve block will be applied post-operatively with guidance of USG and nerve stimulator; Other Names: Regional Anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain assessed by Numeric Rating Scale (NRS)	Pain scores will be recorded as reported by the patient according to NRS	30th minute postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)	Pain scores will be recorded as reported by the patient according to NRS	2nd hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)	Pain scores will be recorded as reported by the patient according to NRS	6th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)	Pain scores will be recorded as reported by the patient according to NRS	12th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)	Pain scores will be recorded as reported by the patient according to NRS	24th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)	Pain scores will be recorded as reported by the patient according to NRS	48th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)	Pain scores will be recorded as reported by the patient according to NRS	1st hour postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Opioids(Tramadol) will be administered to patients in case demanded.	48 hour post-operatively
Ambulation Time	First time a patients can walk around independently	72 hours post-operatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long Term Infection	Surgery site or prosthesis infection in six months following surgery	Six months post-operatively

Collaborators and Investigators

• Sponsor: Bozyaka Training and Research Hospital
• Investigators: Study Director: Zeki T TEKGUL, Associate Professor, Izmir Bozyaka Training and Research Hospital

Publications and helpful links

General Publications

• Karlsen AP, Wetterslev M, Hansen SE, Hansen MS, Mathiesen O, Dahl JB. Postoperative pain treatment after total knee arthroplasty: A systematic review. PLoS One. 2017 Mar 8;12(3):e0173107. doi: 10.1371/journal.pone.0173107. eCollection 2017.
• Tulgar S, Selvi O, Senturk O, Serifsoy TE, Sanel S, Meydaneri S. Evaluation of analgesic regimens in total knee arthroplasty, retrospective study. North Clin Istanb. 2017 Aug 25;4(2):124-130. doi: 10.14744/nci.2017.88598. eCollection 2017.
• Thobhani S, Scalercio L, Elliott CE, Nossaman BD, Thomas LC, Yuratich D, Bland K, Osteen K, Patterson ME. Novel Regional Techniques for Total Knee Arthroplasty Promote Reduced Hospital Length of Stay: An Analysis of 106 Patients. Ochsner J. 2017 Fall;17(3):233-238.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2018
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): February 15, 2019

Study Registration Dates

• First Submitted: June 30, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Concentration; total knee arthroplasty; bupivacaine; post operative analgesia; volume; Femoral nerve block; peripheral nerve block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Bupivacaine
• Other Study ID Numbers: DizFemoralKonsant

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No